Cases for medication delivery devices

ABSTRACT

Cases are provided for carrying medication delivery devices such as auto-injectors, syringes or vials. The cases include a cradling structure to protect the medication delivery device from jostling and impact encountered during transport.

RELATED APPLICATIONS

[0001] This application is a continuation-in-part of U.S. patentapplication Ser. No. 09/853,501, filed May 11, 2001 and incorporatedherein by reference. This application also claims priority from U.S.provisional application No. 60/203,880, filed May 12, 2000 andincorporated herein by reference.

TECHNICAL FIELD

[0002] This invention relates to cases for medication delivery devices,such as injection devices, e.g., auto-injectors and syringes, and vials.

BACKGROUND

[0003] Certain individuals are highly allergic to foods, includingpeanuts, other nuts, wheat, milk and shellfish. Others are highlyallergic to the stings of insects, such as bees and wasps, to latexand/or to medications. When allergic patients are exposed to theseallergens, a severe reaction may occur (anaphylaxis) which may belife-threatening if not treated immediately.

[0004] Epinephrine is generally used to treat an allergic patient at theonset of an anaphylactic reaction. Epinephrine quickly relievesbronchial swelling, constricts blood vessels, relaxes smooth muscles inthe lungs, stimulates the heartbeat, and acts to reverse swelling, thusallowing the patient to function until further treatment can beobtained.

[0005] Because exposure is unpredictable, the reaction can occurquickly, and the patient may not be near medical help at the time ofexposure, patients who are subject to severe anaphylactic reactions mustcarry epinephrine at all times. It is also necessary that the patient beable to self-administer the epinephrine while experiencing an allergicreaction. To address this need, epinephrine is generally prescribed inan auto-injector, e.g., a device commercially available under thetradename “EpiPen”. The auto-injector has a spring-activated, concealedneedle that, when triggered, springs forward to deliver a dose ofepinephrine.

[0006] While epinephrine auto-injectors are life-saving devices whenproperly cared for and used, a number of safety precautions should beobserved with these devices.

[0007] It is important that the auto-injector be used only forintramuscular (rather than intravenous) injection. Currently,manufacturers generally instruct that the auto-injector be used only onthe patient's thigh. Injection of epinephrine into other areas can bedangerous. For example, injection into an extremity, such as a hand orfoot, can shut off blood supply to that area, resulting in potentialdamage to the extremity. Vascular injection can also be potentiallydangerous because systemic delivery of the epinephrine may causecomplications in some patients due to a sharp rise in blood pressureproduced by the epinephrine.

[0008] Jostling and bumping of the auto-injector while the patient iscarrying the auto-injector has been known to cause accidental triggeringof the spring mechanism. Accidental triggering of the auto-injector canresult in injury to the patient or a caregiver or bystander. Also,accidental triggering may exhaust the epinephrine in the auto-injector,so that the epinephrine is not available when needed during ananaphylactic reaction.

[0009] The patient may suffer extreme illness and even death if theauto-injector is not in useable condition when it is needed. Forexample, the patient may not be able to self-inject the epinephrine ifthe spring-activation mechanism has been damaged by jostling or impactof the auto-injector during storage and transport by the patient.

[0010] The patient is also in danger if the medicine contained in theinjector has deteriorated. Epinephrine is heat and light-sensitive, andas a result if the auto-injector is exposed to direct sunlight orextreme heat the epinephrine may oxidize, potentially rendering itineffective. Epinephrine turns brown when oxidized, so auto-injectorsare typically provided with a window to allow the patient to regularlyinspect the color of the medication.

[0011] Thus, it is important that the auto-injector be stored andcarried in a case that protects the auto-injector from accidentaltriggering, damage due to jostling or impact, and exposure to light. Itis also crucial that the patient or a caregiver (potentially a smallchild or elderly family member) be able to remove the auto-injector fromthe case easily and quickly in a crisis situation.

[0012] The Epi-Pen auto-injector is generally supplied by themanufacturer in a thin plastic tube. This tube provides some protectionfrom light, but does not cushion the auto-injector to protect it fromjostling or impact. Accessory cases are available, but many of thesecases are not puncture proof, may not be easily openable in a crisissituation, and/or do not adequately protect the auto-injector fromjostling or impact. It may also be difficult to fit prescription ormedical information into some accessory cases.

[0013] In some cases, a single dose of epinephrine may not be sufficientto treat a patient, for example if the patient is suffering fromextremely severe anaphlaxis. Thus, some highly allergic patients mayneed to carry more than one auto-injector. Doing so can also serve as aprecaution if one of the auto-injectors proves to be in an unusablecondition, or is not properly administered to the patient.

[0014] After an auto-injector has been used, the needle of the injectorremains exposed, presenting both a danger to persons handling theexpended auto-injector and a bio-hazard disposal problem. After using anauto-injector, a patient is generally directed to transport the usedapparatus to the emergency room or physician's office such that medicalpersonnel can determine the amount of medication that the patientreceived during usage of the device. Transport of the apparatus with anexposed needle can prove cumbersome and dangerous.

[0015] It is recommended that persons in need of auto-injectors carry atleast two auto-injectors with them at all times for double life-savingprotection. If one auto-injector fails, a back-up device is immediatelyavailable for application. In addition, the medication injected into thepatient from a typical auto-injector may only last for a short period oftime, often up to 15 minutes, and an additional dose of medication mayneed to be administered thereafter until a patient can reach a medicaltreatment facility. It is therefore desirable to have a mechanismwhereby two auto-injector cases may be attached together for convenienttransport.

[0016] Many auto-injectors are provided to the consumer as packagedwithin a thin plastic tube, usually amber in color, with a plastic,friction-fit end-cap closure. In some instances, a consumer ormanufacturer may not desire to remove the auto-injector from theoriginal tube in which it is packaged, but the consumer may still wantthe benefits of a protective carrying case.

SUMMARY

[0017] The present invention features cases for medical injectiondevices, e.g., auto-injectors, which protect the injection device fromdamage and protect the device and the patient from accidental triggeringof the auto-injection mechanism. These cases also allow the patient or acaregiver to easily and quickly access the device in an emergencysituation.

[0018] In one aspect, the invention features a case for a medicationdelivery device including (a) a container body defining an open chamberconstructed to receive the medication delivery device; (b) a lidconstructed to cover the open chamber; and (c) a cradling structure,within the chamber, constructed to hold the medication device securelyin a predetermined position during transport of the case.

[0019] In another aspect, the invention features a case for a medicationdelivery device including (a) a container body defining an open chamberconstructed to receive the medication delivery device; (b) a lidconstructed to cover the open chamber; and (c) a latch constructed tomaintain the lid in a closed position and to provide a double-latchingfunction. The latch includes (i) a latch member, the latch memberincluding a latch touch fastener and the container body including acooperating body touch fastener constructed to engage the latch touchfastener when the latch member is closed, (ii) a latch hinge joining thelatch member to the lid, the hinge member being constructed to allow thelid to stay open without being held open, and (iii) a member constructedto engage a portion of the container body in an interference fit.

[0020] In a further aspect, the invention features a case for amedication delivery device including (a) a container body defining anopen chamber constructed to receive the medication delivery device; and(b) an encapsulating member, disposed at an end of the open chamber,defining a receptacle constructed to receive an end of the medicationdelivery device.

[0021] Some implementations include one or more of the followingfeatures. The receptacle includes a portion for receiving a needle. Theneedle-receiving portion includes a foam and a hard, puncture-proofshell surrounding the foam. The receptacle includes a portion forreceiving a proximal end of the medication delivery device, andpreventing force from being applied to the proximal end during storageof the medication delivery device in the case. The receptacle isconstructed to pivot between a first position in which the receptacle iswithin the chamber and its long axis is parallel to a long axis of thecase, and a second position, in which at least a portion of thereceptacle extends out of the chamber. The receptacle may be constructedto pivot through an angle of about 90 degrees.

[0022] In yet another aspect, the invention features a case for amedication delivery device including a container body defining an openchamber constructed to receive the medication delivery device, thecontainer body including a connecting device, for connecting thecontainer body to another, similar container body, and a receivingportion, for receiving a corresponding connecting device of anothercase.

[0023] Some implementations may include one or more of the followingfeatures. The cradling structure includes a cradle having a curvedsurface. The curved surface has a curvature that substantiallycorresponds to the curvature of a curved portion of the medicationdelivery device. The cradling structure further includes a foam layercovering at least a portion of the curved surface of the cradle. Thefoam layer has a thickness of from about 1 to 3 mm. The cradlingstructure further includes a cradle guide. The cradling structure isconstructed so that the medication delivery device press-fits into thecradling structure. The cradling structure is constructed so that themedication delivery device will not fall out of the cradling structurewhen the lid is open and the open chamber is inverted. The cradle guideis constructed to position the medication delivery device in apredetermined location within the open chamber. The latch memberincludes a latch touch fastener and the container body includes acooperating body touch fastener constructed to engage the latch touchfastener when the latch member is closed. The touch fasteners includeelements of a hook and loop type fastener. The latch includes a memberconstructed to engage a portion of the container body in an interferencefit. The medication delivery device includes an auto-injector. Thecontainer body is puncture-proof. The container body has a wallthickness of from about 1 to 4 mm. The container body includes ABSplastic. The case further includes needle ribs disposed within thechamber and constructed to receive a needle portion of the medicaldelivery device.

[0024] Among the advantages of the invention, the cases are very easy toopen, even by individuals with compromised dexterity, e.g., an elderlyperson, small child, or patient suffering from an allergic reaction.When the case has been opened, the injection device will not fall out ofthe case, and yet is easily removed by the user. This feature reducesthe risk that a user will have to pick up a dropped injection device orfumble around during a crisis.

[0025] While the case is easy to open, it also fastens securely toresist inadvertent opening, and thus prevent loss of or damage to theinjection device, and to prevent accidental triggering if the device isan auto-injector.

[0026] The cases include a cushioned cradling system, which isconstructed to prevent the device from falling out, as discussed above,and to prevent damage to the injection device from jostling or impactduring storage and transport. In some implementations, the cushioning iswhite, to allow the patient to more easily determine whether thesolution in the injection device has become discolored, e.g., due tooxidation.

[0027] The cases are rigid and puncture-proof, i.e., will prevent aneedle from puncturing through the case to its outer surface, protectingthe patient and others from puncture wounds. The cases are alsolightweight and compact, allowing the case to be easily carried at alltimes.

[0028] In some implementations, the cases are designed to allow thepatient to conveniently carry other medication, e.g., antihistaminetablets, more than one injection device, a prescription for theinjection device, and important medical information.

[0029] In some implementations, the case includes a ‘sharps container’wherein the exposed needle portion of the auto-injector is inserted intoan inner core of dense foam that encloses the needle end completely. Theinner foam core is encapsulated within a hard plastic outer shell forfurther protection of the exposed needle. The “sharps container” featureboth safely holds an unused auto-injector, and facilitates safe handlingand proper disposal of a used auto-injector. A removable label may beprovided to immediately identify the used auto-injector as hazardousmaterial. The label may be applied around the outside of the casecreating a seal and preventing unnecessary opening and exposure of acase containing hazardous material.

[0030] In some implementations of this invention, two cases can beremovably connected in order to allow the consumer flexibility ofcarrying one or two devises. The connecting mechanism is designed toconnect the cases from bottom to bottom, thus ensuring access to theauto-injectors housed inside the cases through the top lid of eithercase. The connecting mechanism may be an integral design that does notrequire external parts for implementation, or may use an externalconnecting part.

[0031] In some implementations, an interior portion of the case mayinclude a cradle that is specifically designed to hold an auto-injectorthat is contained within its manufacturer's packaging. The cradle isdimensioned to accommodate the packaging, e.g., a thin-walled plastictube. The cradle may include a foam layer, or the foam layer may beomitted. The case length may also be modified to accommodate the tube.The case may de designed to hold one or more auto-injectors within thepackaging tube.

[0032] Other features and advantages of the invention will be apparentfrom the description and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

[0033]FIG. 1 is a perspective view of an auto-injector case according toone embodiment of the invention. FIG. 1A is a perspective view of theauto-injector case in an open position. FIG. 1B is a perspective view ofthe open auto-injector case with an auto-injector inside.

[0034]FIG. 2 is a front plan view, and FIG. 2A is a side plan view ofthe auto-injector case of FIG. 1.

[0035]FIG. 3 is a top sectional view of the auto-injector case of FIG. 1taken along line 3-3 in FIG. 2.

[0036]FIG. 4 is a sectional view of the auto-injector case of FIG. 1taken along line 4-4 in FIG. 3.

[0037]FIG. 5 is a sectional view of the auto-injector case of FIG. 1taken along line 5-5 in FIG. 4.

[0038]FIG. 6 is a sectional view of the auto-injector case of FIG. 1taken along line 6-6 in FIG. 4, showing the latch in an open position.

[0039]FIG. 7 is a sectional view of the auto-injector case of FIG. 1taken along line 7-7 in FIG. 4, with a used injector pin in the case.

[0040]FIG. 8 is a sectional view of the auto-injector case of FIG. 1taken along line 8-8 in FIG. 3, with a used injector pin in the case.

[0041]FIG. 9 is a top plan view of the auto-injector case of FIG. 1 withthe sliders closed.

[0042]FIG. 10 is a top plan view of the auto-injector case of FIG. 1with the sliders open.

[0043]FIG. 11 is a bottom plan view of the auto-injector case of FIG. 1with a belt clip in place.

[0044]FIG. 12 is a bottom plan view of the auto-injector case of FIG. 1with the belt clip omitted.

[0045]FIGS. 13 and 13A are examples of labels containing a patient'smedical information.

[0046]FIG. 14 is a top view with the lid partially broken away, and FIG.15 is a cross-sectional view of an auto-injector case for carrying twoauto-injectors.

[0047]FIG. 16 depicts a cross section of the interior of anauto-injector case with an un-used auto-injector resting inside theun-used needle encapsulator.

[0048]FIG. 17 depicts a magnified view of the needle end of theauto-injector fully inserted into the needle encapsulator.

[0049]FIG. 18 depicts the un-used auto-injector pivoting up to allow theun-used auto-injector to be removed from the case and encapsulator.

[0050]FIG. 19 shows a magnified partial view of the exposed needle ofthe used auto-injector inserted into the dense foam core of theencapsulator.

[0051]FIG. 20 shows the used auto-injector returned to position in thefoam lined cradle.

[0052]FIG. 21 shows the bio-hazard label. FIGS. 21A and 21B are,respectively, side and top views of the biohazard label of FIG. 21applied around the outside of an auto-injector case containing anejected needle.

[0053]FIG. 22a shows a connector clip that is permanently attached toone bottom end of a case, in a stored position. FIG. 22b shows theconnector clip rotated out of the stored position and into position toconnect to a second case.

[0054]FIG. 23 shows a cross-section of two cases with connector clipsflipped out and in ready position to be clipped together.

[0055]FIG. 24 shows a cross-section of two cases that have been clippedtogether.

[0056]FIG. 25 shows an interior view of a case holding twoauto-injectors housed within their respective plastic tube packaging. Inthis embodiment, the foam lining has been omitted from the cradle. FIG.25A is a side view of the plastic tube packaging.

DETAILED DESCRIPTION

[0057] Referring to FIGS. 1-1B, an auto-injector case 20 includes acontainer body 25 that is constructed to receive an auto-injector 10(FIG. 1B) in a cradling engagement, as will be discussed below. The case20 also includes a lid 21 that securely engages the container body 25.The lid is mounted on the container using a pair of hinges 30 that areconstructed to maintain the lid in a desired position after the lid hasbeen opened by a user (i.e., to prevent the lid from self-closing if itis not held open). This feature of the hinges is generally provided byusing a hinge with a tight friction fit. This feature facilitatesremoval of the auto-injector 10 from the case 20, and is particularlyhelpful for users who have a low level of dexterity.

[0058] The case 20 also includes a secure, yet easily openable, latch32. Latch 32 provides a double latching function, securing the lid bothby an interference fit with the rim of the container 25 and byengagement of a touch fastener element, as will be discussed in detailbelow.

[0059] The case 20 should generally be able to withstand the high impactforce that may occur if the auto-injector is accidentally triggered whenit is inside the case. The lid 21 and container body 25 are formed of arigid, high-strength plastic, for example ABS, so thatpuncture-proofness can be provided with a relatively thin wallthickness. However, if desired, other plastics may be used, e.g.,polyethylene, polypropylene, and other moldable thermoplastics. If ABSor a similar plastic is used, the wall thickness is generally from about1 to 4 mm, more preferably about 1.0 to 2.5 mm. If other plastics areused, the wall thickness is selected to provide puncture-proofness.Puncture-proofness is further enhanced by an arcuate rib 90 that extendsdownwardly from the lid 21 in front of the needle end of theauto-injector 10 when the case is closed. Arcuate rib 90 is discussedfurther below.

[0060] Lid 21 includes a hinge portion 16, which cooperates with acorresponding hinge portion 18 on latch member 19 to provide a latchhinge 17. The latch hinge 17 is constructed to hold the latch member 19in a fixed position when the latch member 19 is fully extended. Thisfeature keeps the latch member 19 from flopping down when the user istrying to open the lid, further enhancing the ease with which the lidcan be opened. When the latch member 19 is in its fixed position it alsoserves as a handle which can be used to lift the lid 21.

[0061] Referring to FIG. 6, latch member 19 includes a touch fastenerstrip 34 on its inner surface 64. Touch fastener strip 34 is positionedfor engagement with a cooperating touch fastener strip 35 on the outersurface 66 of container body 25. Touch fastener strips 34 and 35 may be,for example, male and female portions of a hook-and-loop fastener, forexample fasteners commercially available under the tradename VELCRO. Theengagement of the touch fastener holds the latch member securely inplace against the outer surface of the container body 25, while allowingthe latch member to be easily disengaged by a user.

[0062] As shown in FIG. 1A, hinge portion 16 includes a groove 68 thatis constructed to engage ridge 70 on rim 72 of the container body 25 inan interference fit to further secure the lid in a closed position. Thisprovides a back-up latching mechanism, in the event that the touchfastener strips 34, 35 do not engage when the user closes the lid, or inthe unlikely event that the touch fastener becomes accidentallydisengaged. The engagement of ridge 70 in groove 68 is secure againstaccidental disengagement, but easily snaps open in response to a userapplying upward pressure to the latch member 19. This snap fit isfurther enhanced by an interference engagement between rim 74 of lid 21and rim 72 of the container body 25.

[0063] As noted above, the container body 25 includes a cradlingstructure that prevents jostling and bumping of the auto-injector whenit is carried by the patient. Referring to FIGS. 1A and 6, the innersurface of container body 25 includes a cradle 39 that has a curvedsurface with a curvature that conforms to the curvature of theauto-injector. For an EpiPen auto-injector, a suitable radius ofcurvature R is about 8 to 10 mm, e.g., about 9 mm.

[0064] A foam pad 42 is mounted on the curved surface of the cradle 39,to provide a snug, resilient engagement between the auto-injector andthe cradle 39. Preferably, the foam pad 42 and cradle 39 are dimensionedso that the auto-injector press-fits into the cradle in response togentle pressure by the user, or in response to the pressure that isapplied to the auto-injector when the lid is closed, if the user has notalready pressed the auto-injector into the cradle.

[0065] The foam pad 42 cushions the auto-injector against impact,further reducing the likelihood of accidental triggering. By resilientlyengaging the auto-injector, the foam pad 42 also prevents theauto-injector from falling out of the container when the lid is opened.Preferably, the auto-injector fits sufficiently snugly into the cradle39 so that the open case 20 (FIG. 1B) can be completely inverted withoutthe auto-injector falling out. By reducing the likelihood that theauto-injector will be dropped when the case is open, this feature alsoreduces the danger that precious treatment time will be wasted while thepatient or a caregiver struggles to find a dropped auto-injector.Similarly, this feature reduces the likelihood of accidental triggering,which may occur if an auto-injector is dropped.

[0066] Suitable foams include closed cell, low to medium density foams.Suitable foams have sufficient compressibility to provide the cushioningand resilient engagement features discussed above. Suitable foamsinclude polyethylene foams. Preferably the foam does not contain anylatex, to avoid allergic reactions. The radius of curvature of thecradle can be adjusted based on the density of the foam to provide adesired degree of resilient engagement (generally, lower density foamswill require a smaller radius cradle).

[0067] The foam pad is sufficiently thick to provide cushioning andresilient engagement, but sufficiently thin so that the auto-injectorcan be readily removed from the cradle by the patient or a caregiver.Preferably, the foam pad is from about 1 to 3 mm thick whenuncompressed, more preferably about 1.25 to 1.75 mm thick.

[0068] Preferably, the foam pad is white, so that the patient orcaregiver can easily observe whether the liquid in the auto-injector isclear, as it should be for an epinephrine injector, or whether theliquid is colored, indicating oxidation and/or deterioration.

[0069] In some applications, it may be useful to provide additional foampadding on the inside surface of lid 21. If such padding is used, itshould be dimensioned and positioned so that the lid will closeproperly.

[0070] Referring to FIGS. 1A, 1B and 4, the container body 25 alsoincludes a cradle guide 76 that extends generally perpendicular to thelongitudinal axis of the auto-injector 10 when the auto-injector is inplace (FIG. 1B). Cradle guide 76 includes a curved opening 78 throughwhich the smaller diameter, forward portion 80 of the auto-injector canextend. Curved edge 82 of cradle guide 76 acts as a stop, properlypositioning the larger diameter portion 84 of the auto-injector in thecradle 39 for easy removal of the auto-injector. The cradle guidepositions the auto-injector so that there is a gap 86 on each end of theauto-injector (FIG. 1B), allowing a user to easily slip a fingertip intothe gap to lever the end of the auto-injector out of the cradle 39.

[0071] After the auto-injector has been triggered, whether intentionallyor unintentionally, the needle is exposed and remains exposed, thuscreating a danger of puncture wounds. If the auto-injector has beentriggered intentionally, it is necessary for the patient to bring theauto-injector to the treating physician so that the physician will knowhow much epinephrine has been taken. As shown in FIGS. 7 and 8, thecontainer body includes needle ribs 40, which enclose the needle 88during transport, providing a safe, puncture-proof way to carry the usedauto-injector to the hospital or treating physician. The needle ribs 40also reduce the risk of accidentally stabbing a finger when the usedauto-injector is removed from the case, by preventing the user fromgrasping the needle by the tip during removal. Needle ribs 40 arepreferably substantially flat plastic members, integrally molded withthe container body 25 of the same puncture-proof material. Preferablythe ribs are from about 1.0 to 2.5 mm thick.

[0072] The lid 21 includes an arcuate rib 90, extending downwardly fromthe inner surface of the lid, which is positioned in front of the needleend of the auto-injector when the lid is closed. Arcuate rib 90 enhancesthe puncture-proofness of the case 20, because in the event ofaccidental triggering of the auto-injector the arcuate rib 90 willeither push the needle 88 down between the ribs, or force it partiallyback into the auto-injector, depending upon the angle at which theneedle is discharged. The arcuate rib 90 is positioned so that it willnot force the needle fully back into the auto-injector, so that it willbe possible for the user to observe that accidental triggering hasoccurred. If the arcuate rib is formed of ABS or a plastic with similarmechanical properties, the arcuate rib is preferably about 1 to 3 mmthick, e.g., about 2 mm. The arcuate rib is mounted on a support that ispositioned directly in front of the needle of the auto-injector, tofurther enhance puncture-proofness. The support preferably has athickness of from about 1 to 3 mm.

[0073] In some cases, a patient may have an allergic reaction that isnot severe enough to warrant injection, and yet requires treatment,e.g., with an antihistamine such as BENADRYL antihistamine. To allow thepatient to keep all of his or her emergency allergy medication togetherin one place, the container body 25 also includes medication slots 43for holding two push-through packets containing antihistamine tablets.

[0074] Some emergency medical personnel are reluctant to administer anepinephrine injection without a prescription. To avoid this problem, thecontainer body 25 is preferably sized to permit the patient to carry afolded prescription in prescription storage location 49.

[0075] To allow the patient to provide medical history information to acaregiver in an emergency, while keeping the information private atother times, the case 20 includes sliders 29 which are movably mountedon lid 21 to slide along tracks 37 (FIGS. 9 and 10). In the openposition, shown in FIG. 10, the sliders 29 reveal a medical historypanel 36. When the sliders are in the closed position, shown in FIG. 9,the information on the medical history panel 36 remains private.

[0076] A label 50, e.g., as shown in FIG. 13A, can be mounted on themedical history panel, giving the patient's medical and emergencyinformation 52, e.g., name, phone number, allergies, and doctor's nameand phone number.

[0077] A more detailed label 50′ that may be used is shown in FIG. 13.This label includes medical information symbols 51, a name plate 52′,areas that can be checked off or circled to indicate foods or materialsto which the patient is allergic, e.g., bee sting (53), peanuts (54) orpenicillin (55), and blank areas 60 to allow the patient to fill inother foods/materials that are not listed. Label 50′ also includes a box56 to indicate the expiration date of the auto-injector, identifies theauto-injector as an adult dosage (57) or junior dosage (58), andnotifies a caregiver that a prescription is located in the case (59).

[0078] Labels 50, 50′ are preferably moisture resistant, and users areinstructed to use an indelible marker to fill in the information.

[0079] The case 20 may include various accessories to enable a patientto have it handy at all times.

[0080] For example, a magnet (not shown) can be provided, e.g., on thebottom outer surface of the container body, to allow the case 20 to beremovably mounted on a refrigerator, filing cabinet or other convenientmetal area.

[0081] Also, as shown in FIGS. 4, 8 and 11, the case 20 may include aremovable belt clip 44. Belt clip 44 may be of any suitable material,e.g., plastic or metal, and is removably inserted into belt clip hole 46by compressing the belt clip prongs 45 (FIG. 11). Belt clip hole 46 iscovered with a cap 47 (FIG. 12) when the belt clip is not in use.

[0082] The case 20 may also be provided with a self-adhering strap (notshown), e.g., of a touch fastener material such as VELCRO fastenermaterial. The self-adhering strap can be threaded through the belt cliphole 46 and attached to itself to form a loop. A hook, e.g., asnap-hook, can be attached to the loop to allow case 20 to be hung froma knapsack, wall hook or other location. The self-adhering strap canalso be looped through the belt clip holes of two cases, to hold thecases together, e.g., for patients who carry a second auto-injector as aback-up or for caregivers who are responsible for the storage ofinjectors for more than one user.

[0083] Other embodiments are within the scope of the following claims.

[0084] For example, while the discussion above has focused on cases forepinephrine auto-injectors, the cases described above are suitable foruse with auto-injectors containing other types of medication, e.g.,antidotes for chemical poisoning such as are used in militaryapplications. Also, while the cases described above are particularlysuitable for use with auto-injectors, they may also be used with othertypes of medication delivery devices, for example, syringes containingmedications such as insulin or morphine, and fragilemedication-containing vials. If the case is used with a medication thatmust be kept cold, e.g., insulin, space can be provided in the case fora tiny cold pack

[0085] Moreover, while the latch in the implementation described aboveis secured using a touch fastener, any desired type of fastener may beused, as long as the fastener is relatively secure and can be easilydisengaged by a user. Other suitable fasteners include snaps, magnetsand pressure sensitive adhesives.

[0086] Additionally, the sliders discussed above may be replaced by aflap or other structure that allows the patient information to beconcealed, or may be omitted and the patient information provided insidethe case.

[0087] While the case described above is sized to hold a singleauto-injector, in other implementations the case is sized to hold twoauto-injectors side by side. In these implementations, the case includestwo cradles and two sets of needle ribs, e.g., as shown in FIGS. 14 and15.

[0088] As depicted in FIG. 16, a needle encapsulator (104) may be builtinto the interior of the case at the end intended to accommodate theneedle end of the auto-injector (103). The needle encapsulator generallyconsists of a rigid tube-shaped outer shell composed of a hard plasticor other suitable material that has a hollow opening on one end (101)and is tapered at the other end (102). Inside the tapered end (102) ofthe encapsulator (104) is a dense foam inner core (105). The un-usedauto-injector's needle end (103) rests inside the hollow end (101) ofthe encapsulator inside the case (108). The needle end (103) fitsloosely into the hollow end (101) of the encapsulator ensuring easyremove of the unused injector. The foam layer (121) on the inside of thecradle frictionally fits the body of the auto-injector (107) preventingit from jostling and slipping out of the case.

[0089] The hollow end of the encapsulator (101) shown in FIG. 17 issized at a specific length to allow space (122) between the needle end(103) of the auto-injector and the flat inside surface (123) of theencapsulator (104). The space (122) is generally greater than 1.0 mm.External force applied to the needle end (103) of the auto-injector isrequired to discharge the needle and medicine inside the case. Thehollow end (101) of the encapsulator (104) is sized to bottom-out on theshoulder of the auto-injector (124) preventing any force from beingapplied to the needle end (103) of the auto-injector (107), therebypreventing accidental discharge.

[0090]FIG. 18 shows the encapsulator (104) as it pivots about a pivotinghead (110), such as on a pivoting post or on a pivoting ball, such thatthe encapsulator with unused auto-injector rotates easily upward in asingular plane perpendicular to the bottom of the case when a force isapplied at the grey end cap end (111) of the auto-injector by a personremoving the auto-injector (107) from the case (108). Once theencapsulator (104) with un-used auto-injector (107) is pivoted upward,the un-used auto-injector (107) easily slides out of the encapsulator(104). The preferred range of pivot of the auto-injector (107) to alloweasy insertion into and removal from the encapsulator (104) is from 0degrees to 90 degrees from the inside surface of the case.

[0091] Referring to FIG. 19, the needle (112) of the used auto-injector(120) shown in FIG. 19 remains permanently exposed and attached to theauto-injector (120) after injection. The exposed needle (112),contaminated with medicine and blood residue, is inserted back into theneedle encapsulator (104) where the needle is removably imbedded intothe dense foam core (105) at the tapered end (110) of the encapsulator(104). The used auto-injector (120) is then pivoted back down into thefoam-lined cradle (121) of the case for safe transport (FIG. 20).

[0092] In the embodiment shown in FIGS. 16-20, the length of the case isgenerally about 175.0 mm, to allow room for the needle encapsulator(104). Advantageously, the encapsulator (104) also acts as apuncture-proof feature. In case of malfunction of an auto-injectorstored inside the case, the fully ejected needle (112) is completelyencased and cannot extend through the wall at the pivoting end of theneedle encapsulator (106) or through the outside wall of the case.

[0093] A label indicating ‘Bio-Hazardous Material’ (126), shown in FIG.21, may be included with each case and may be applied by the consumerafter the auto-injector is dispensed and returned to the case for safehandling. The Bio-Hazard label (126) is wrapped around the outsidesurface of a closed case (127) containing a dispensed auto-injector, asshown in FIGS. 21A and 21B. The label (126) is positioned in such a wayaround the short circumference of the case that it seals the case shutand prevents the case from being opened without purposefully breakingthe label.

[0094] In order to connect two cases together, a connecting device, or‘connector clip’ (114), shown in FIGS. 22a and 22 b, is stored within arecess (113) at one end of the case located on the bottom surface,preferably at the needle end of the case. The connecting device (114)generally consists of hard plastic or other suitable material, and isshaped as a rectangular clip. The connecting device (114) is designedwith an attached end (128) that is permanently connected to the casewith a metal pin or other suitable method. The free end (129) of theconnecting device is designed with an integral snapping mechanism andstores flush with the bottom of the case.

[0095]FIG. 23 shows how to connect to cases together. The connectingdevice (114) may be released from the exterior of the case and extendedout perpendicularly to the case. Once extended, the connecting device(114) is inserted into a receiving slot (115) located on the secondcase, preferably at the opposite end, or non-needle tip end, of thecase.

[0096] The receiving slot (115) may have a snap portion 116, to allowthe connecting device to snap securely into the receiving slot (115).Because each case would have both a connecting device (114) and areceiving slot (115) integrally attached to the case at opposite ends,two cases may be clipped together by extending each connecting devicefrom each case and facing the cases opposite each other, and by snappingeach connecting device (114) into the corresponding opposed receivingslot (115) as depicted in FIG. 24. The bottom surfaces (130) of thecases are connected, providing ample access for either case top to beunobstructively opened to access either auto-injector contained inside.Once clipped together, the cases may then be separated by applying aforce to the snap portion (116) of each connecting device perpendicularto the length of the connecting device (114) to release the snapmechanism.

[0097]FIG. 25 shows an interior view of the case (131) holding twoauto-injectors (117) housed within their plastic tube packaging (118)(FIG. 25A). In this embodiment, the foam linings have been omitted fromthe cradles. The length of the case (119) is enlarged to accommodate themanufacturer's tube and is generally about 172.0 mm in length.

What is claimed is:
 1. A case for a medication delivery devicecomprising: a container body defining an open chamber constructed toreceive the medication delivery device; a lid constructed to cover theopen chamber; and a cradling structure, within the chamber, constructedto hold the medication device securely in a predetermined positionduring transport of the case.
 2. The case of claim 1 wherein thecradling structure comprises a cradle having a curved surface.
 3. Thecase of claim 2 wherein the curved surface has a curvature thatsubstantially corresponds to the curvature of a curved portion of themedication delivery device.
 4. The case of claim 2 wherein the cradlingstructure further comprises a foam layer covering at least a portion ofthe curved surface of the cradle.
 5. The case of claim 1 wherein thecradling structure further comprises a cradle guide.
 6. The case ofclaim 1 wherein the cradling structure is constructed so that themedication delivery device press-fits into the cradling structure. 7.The case of claim 1 wherein the cradling structure is constructed sothat the medication delivery device will not fall out of the cradlingstructure when the lid is open and the open chamber is inverted.
 8. Thecase of claim 1 further comprising a hinge joining the lid to thecontainer body.
 9. The case of claim 8 wherein the hinge is constructedto allow the lid to stay open without being held open.
 10. The case ofclaim 1 wherein the medication delivery device comprises anauto-injector.
 11. A case for a medication delivery device comprising: acontainer body defining an open chamber constructed to receive themedication delivery device; and an encapsulating member, disposed at anend of the open chamber, defining a receptacle constructed to receive anend of the medication delivery device.
 12. The case of claim 11, whereinthe receptacle includes a portion for receiving a needle.
 13. The caseof claim 12 wherein the needle-receiving portion includes a foam. 14.The case of claim 13 wherein the needle-receiving portion furtherincludes a hard, puncture-proof shell surrounding the foam.
 15. The caseof claim 11 wherein the receptacle includes a portion for receiving aproximal end of the medication delivery device, and preventing forcefrom being applied to the proximal end during storage of the medicationdelivery device in the case.
 16. The case of claim 11 wherein thereceptacle is constructed to pivot between a first position in which thereceptacle is within the chamber and its long axis is parallel to a longaxis of the case, and a second position, in which at least a portion ofthe receptacle extends out of the chamber.
 17. The case of claim 16wherein the receptacle is constructed to pivot through an angle of about90 degrees.
 18. The case of claim 11 further comprising a biohazardlabel.
 19. The case of claim 11 further comprising a lid constructed tocover the open chamber.
 20. The case of claim 11 further comprising acradling structure, within the chamber, constructed to hold themedication device securely in a predetermined position during transportof the case.
 21. A case for a medication delivery device comprising: acontainer body defining an open chamber constructed to receive themedication delivery device; a lid constructed to cover the open chamber;a cradling structure, within the chamber, constructed to hold themedication device securely in a predetermined position during transportof the case; wherein the container body includes a connecting device,for connecting the container body to another, similar container body,and a receiving portion, for receiving a corresponding connecting deviceof another case.
 22. The case of claim 21 wherein the connecting deviceincludes a clip member and the receiving device includes a slotdimensioned to receive the clip member.
 23. The case of claim 21 furthercomprising a lid constructed to cover the open chamber.
 24. The case ofclaim 21 further comprising a cradling structure, within the chamber,constructed to hold the medication device securely in a predeterminedposition during transport of the case.